FDA Inspection 697665 — Sunandana Chandra, M.D.
The FDA completed an inspection of Sunandana Chandra, M.D. on October 27, 2010 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 27, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7527 | 21 CFR 312.62(a) | Unused drug disposition (investigator) |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |